Advanced or Metastatic Solid TumorsPhase 1NCT02261532
A Phase I Study of TAS-102 in Solid Tumors
A Phase 1 study testing TAS-102 in people with Advanced or Metastatic Solid Tumors, run by Taiho Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- TAS-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jun 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Has provided written informed consent prior to performance of any study procedure.
- 2. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
- 3. Is able to take medications orally.
- 4. Has adequate organ function (bone marrow, kidney and liver).
- 5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.
Who cannot join
- 1. Has received TAS-102.
- 2. Has suffered serious complications.
- 3. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
- 4. Has had prior gastrectomy.
- 5. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors
The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.
Read the detailed description
This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- TAS-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102Drug
TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 | Experimental | Not described Receives: Drug: TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum Plasma Concentration) of FTD
Measured: Multiple time points on Day 1 and Day 12 of Cycle 1.
Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
Measured: Multiple time points on Day 1 and Day 12 of Cycle 1.
AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
Measured: Multiple time points on Day 1 and Day 12 of Cycle 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261532
- Sponsor's protocol ID
- 10040100
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2014
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wang X, Zhou J, Li Y, Ge Y, Zhou Y, Bai C, Shen L. Pharmacokinetics, Safety, and Preliminary Efficacy of Oral Trifluridine/Tipiracil in Chinese Patients with Solid Tumors: A Phase 1b, Open-Label Study. Clin Pharmacol. 2020 Apr 9;12:21-33. doi: 10.2147/CPAA.S232104. eCollection 2020.
PubMed 32308505
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02261532
- Acronym / sponsor ID
- 10040100
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 18 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.
Detailed description
This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 | Experimental | Drug: TAS-102 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Has provided written informed consent prior to performance of any study procedure.
- 2. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
- 3. Is able to take medications orally.
- 4. Has adequate organ function (bone marrow, kidney and liver).
- 5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (5 listed)
- 1. Has received TAS-102.
- 2. Has suffered serious complications.
- 3. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
- 4. Has had prior gastrectomy.
- 5. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-102TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. | Drug | TAS-102 |
Primary outcome
Cmax (Maximum Plasma Concentration) of FTD
Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32308505Wang X, Zhou J, Li Y, Ge Y, Zhou Y, Bai C, Shen L. Pharmacokinetics, Safety, and Preliminary Efficacy of Oral Trifluridine/Tipiracil in Chinese Patients with Solid Tumors: A Phase 1b, Open-Label Study. Clin Pharmacol. 2020 Apr 9;12:21-33. doi: 10.2147/CPAA.S232104. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS-102 in people with Advanced or Metastatic Solid Tumors, run by Taiho Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (Maximum Plasma Concentration) of FTD (time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.